C61
Conditions
Interventions
Group 1: Routine therapy with 3- or 6-month formulation Triptorelin Pamoate. QoL questionnaire on day 1, month 6 and month 12.
Sponsors
Ipsen Pharma GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Eligible subjects should fulfill the following: • Provision of written informed consent • Male subjects aged 18 years and older with capacity to consent • Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy or already receiving hormonal deprivation therapy (in this case, the preceding therapy and the reason for change of therapy have to be documented) • Definition of locally advanced: T3 or T4 or N1 with any T, M0 • Definition of metastatic: any T, any N, M1
Exclusion criteria
Exclusion criteria: As this is a non-interventional study, no exclusion criteria apply. The investigator has to follow the information in the SmPC, e.g. contraindications, restrictions, precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective(s) To collect data on the quality of life of subjects with advanced prostate cancer treated with triptorelin pamoate 3 month formulation or 6 month formulation and to assess the responder rate at month 6, using the PORPUS questionnaire. (Definition Responder: Improvement of = 5 points in the PORPUS total scale). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective(s) 1 To assess the responder rate at month 12 (definition: improvement of = 5 points on the overall PORPUS scale) 2 To assess the changes of overall PORPUS scores at month 6 and at month 12 versus baseline 3 To assess the effectiveness of the treatment by the course of PSA and testosterone values within 6 and 12 months (if available). The validity of the values is guaranteed by certified laboratories and the ring test certificates (“Ringversuchszertifikate”) for PSA and testosterone will be collected from the participating sites (see also the corresponding Guideline from the German Medical Association, “Richtlinien der Bundesärztekammer”, “Rili-Bäk”, current version 2010) 4 Analysis of medical history (using all available data as described in the section “Study Evaluations”) 5 To assess the change of Karnofsky Index within 6 and 12 months 6• To assess the change of tumour stadium (TNM) within 6 and 12 months 7 To perform subgroup analyses on quality of life and effectiveness data as a function of hormonal pretreatment of subjects, resulting in separate subject groups, e.g. naïve for hormonal treatment, < 1 year, and = 1 year hormonal pre-treatment (depending on the data structure) 8 To perform subgroup analyses on QoL data as a function of the applied formulation of Pamorelin at the beginning of the therapy and after 6 and 12 months(depending on the data structure) 9 To assess the global evaluation of overall effectiveness by the physician by means of the Karnofsky Index at the beginning of the therapy and after 6 and 12 months. 10 To assess the global impression on tolerability by the subject by means of the PORPUS questionnaire at the beginning of the therapy and after 6 and 12 months. 11 To assess the pain at injection site (Visual Analogue Scale / VAS) at the beginning of the therapy and after 6 and 12 months 12 To assess the subject satisfaction with therapy by means of the PORPUS questionnaire at the beginning of the therapy and after 6 a | — |
Countries
Germany
Contacts
Public ContactHeribert Stiegler
OnkoDataMed GmbH
Outcome results
None listed